(Editor’s note:
IRB Advisor asked IRB and human subjects protection experts from across
the nation to discuss the state of human subjects protection regulations and
how IRBs are interpreting federal requirements. In this issue, we discuss how
IRBs and institutions can improve the informed consent process.)

If someone wants to show
how IRBs and research programs have become burdened with documentation and requirements
that provide no additional quality to the process of protecting subjects, then
the informed consent document is Exhibit A, experts suggest.

"Informed consent documents
used to be in the range of two or three pages," says Bernard Schwetz,
DVM, PhD, director of the Office for Human Research Protections (OHRP).

"Now the documents are
up to 10 pages or more," he says. "There are informed consent documents over
100 pages and, as people have commented, the reason you have an additional 90
pages more than what it used to be is for protecting institutions — not subjects."

While it’d be nice to return
to the two-page consent forms, it might not be possible under the current regulations,
says Robert M. Nelson, MD, PhD, associate professor of anesthesia and
pediatrics at the Children’s Hospital of Philadelphia.

"I would challenge [Bernard
Schwetz] to take the elements in the federal regulations and put them on two
pages," he says.

There is no easy answer
to reducing unnecessary burdens, including the lengthy informed consent forms,
Schwetz notes.

"That’s one of the reasons
I’m trying to bring more people to the table to talk about the function of the
enterprise," he says.

Such discussions in the
past usually involved IRB members, but now it’s important to bring many different
parties to the table, including investigators, lawyers, research executives,
and others, Schwetz says.

"I’m trying to bring a
broader range of people to the table so that when we’re talking about burdens
we don’t just point fingers at the people who are not at the table," he says.
"I’ve sought these people out, group by group, and have talked with them about
my concern for the future success of the research enterprise."

Slowly, this communication
process is building bridges that may lead to better human subjects protection
within an environment that is less burdensome with regard to rules and regulations,
Schwetz says.

"I agree that consent forms
are too long and impossible to understand, and many studies have documented
that," he says. "But the more fundamental question is: What do we hope to achieve
by the consent process?"

Thinking outside the box,
perhaps a solution would be to create a different sort of measure showing the
adequacy of the informed consent process, Nelson suggests.

"Would we be willing to
tell investigators, We won’t look at your consent form, but we will check with
your participants, and let’s see how much they understand of what’s going on?’"
he says. "We could look at the outcomes and not spend as much time on the informed
consent document."

This type of outcomes-based
monitoring would be similar to what has happened in other fields, including
the health care industry, Nelson notes.

"Third-party payers will
relieve institutions from regulations if they meet certain guidelines, such
as relieving someone of having to obtain prior authorization if they are able
to discharge a patient within a certain period of time," he explains. "So are
we willing to move toward that system where we relieve people of the upfront
paperwork and instead use outcomes measures?"

For example, IRBs could
conduct random audits and interviews of research subjects to ascertain how well
they understand the research and their own participation in it.

"If the audit is random
then you’re replacing an upfront review process with a back-end, random auditing
process," Nelson says.

Since IRBs would have to
spend less time on the upfront review process, they might have more time for
a critical analysis of a protocol’s risks, he adds.

Form and process separate

If IRB members want to
monitor a study’s consent process in addition to reviewing the informed consent
document, then they may do so under the current regulations, says Steven
Peckman, associate director for human subjects research at the Office for
Protection of Research Subjects at the University of California-Los Angeles.

Peckman says he agrees
with Nelson that IRBs should spend more time looking at the process of the informed
consent communication because that is more important than the actual informed
consent document.

"There is a place to monitor
the consent document to make sure it all works, but the document is not the
process," Peckman says. "And we’re going down a dangerous road if we think the
document is the process when in my mind the document should serve as a summary
or outline of what needs to be discussed with the subject."

True informed consent occurs
during the process of an investigator and subject discussing the study, while
the informed consent document explains what is discussed in a specific way,
Peckman adds.

"The key word is process,’"
says Mark Hochhauser, PhD, readability consultant and an IRB member at
the IRB at North Memorial Healthcare in Robbinsdale, MN.

"Many IRBs focus way too
much time on consent forms as a piece of paper, and there’s not enough time
devoted to the consent process of the research staff," he says. "IRBs can’t
be the consent process police; they don’t have the money or staff to sit in
and observe what’s going on and make suggestions during the process."

Instead, the question is
"Why can’t multibillion-dollar drug companies write a consent form that’s understandable?"
Hochhauser asks. "It would be nice that instead of having a panel of us folks
at the IRBs and those who are interested in language rewrite consent forms to
have a representative from the drug company write consent forms that could be
understood," Hochhauser adds.

Who will pay?

While it’s a good idea
to have IRBs monitor the informed consent process, this is a costly addition
to the IRB’s duties, and who would pay for it? asks Felix A. Khin-Maung-Gyi,
PharmD, MBA, CIP, chief executive officer of Chesapeake Research Review Inc.
of Columbia, MD, and senior policy fellow with the Center for Drugs and Public
Policy at the University of Maryland in Baltimore.

"The ability of the IRB
to interact with subjects in the informed consent process would be tremendously
valuable, but at the present time I don’t know of any IRB that has the resources
to do those things," he says.

"Informed consent and decision
making are things that require time and effort, and that has to be factored
into the cost of doing business," Khin-Maung-Gyi adds.

Both industry-sponsored
research and federally funded research fail to provide adequate funding for
this level of quality in IRB oversight, and so there are not enough resources
to address these issues, he says.

The most important part
of the informed consent process is not readily accessible to an audit, notes
Dale Hammerschmidt, MD, FACP, associate professor of medicine at the
University of Minnesota Medical School in Minneapolis.

For instance, the IRB has
no control over the actual consent encounter between the principal investigator
and the subject, he says.

"The other thing is the
consent he may be the only retrospective document the person has to look at
a month later when trying to recall something, so it remains important that
it be a good document, even if it is a small part of the process," he says.

"It’s a unique quality
to human life that you devote a lot of energy to tasks you can accomplish rather
than to the ones you wish you could accomplish," Hammerschmidt notes.

Focus on the document

Improving the informed
consent process is an issue that also concerns the Secretary’s Advisory Committee
on Human Research Protection (SACHRP) for the U.S. Department of Health and
Human Services, says Ernest Prentice, PhD, chair of SACHRP and an associate
vice chancellor for academic affairs at the University of Nebraska Medical Center
in Omaha.

"Many IRBs are requiring
some kind of description of the process of consent in forms, but they don’t
pay as much attention to the process as they should," he says. "What they do
is concentrate on the consent document, dotting all i’s, crossing all t’s and
simplifying the language."

SACHRP members have discussed
alternatives, including educating investigators about how to obtain valid and
informed consent and then doing quality outcome assessments, Prentice says.

But to change federal regulations
to permit IRBs to forgo review of informed consent documents in exchange for
providing random audits of the informed consent process, as Nelson proposes,
would not be feasible, he adds.

Changing regulations is
an onerous process, Prentice notes.

"In 1991, you had 17 agencies
sign on to the Common Rule, and to change the Common Rule you have to get all
of these agencies to agree," he explains. "The fact that we got 17 agencies
to agree is remarkable — it will never happen again."

The solution is not in
revising the Common Rule and regulations, but in making OHRP and the Food and
Drug Administration give IRBs clear guidance as to what their expectations are,
Prentice says.

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